Needle holder for a suture package

ABSTRACT

A suture needle holder for a suture package intended to contain an armed suture, comprising a sheet of planar plastic having at least one raised pedestal formed therein, said at least one raised pedestal having at least one slot therein oriented orthogonal to the sheet of planar plastic, said at least one slot having an open portion and a needle-holding portion releasably holding a portion of the length of a suture needle therein with the length of the suture needle lying in a plane parallel to the sheet of planar plastic, wherein the open portion of the slot is of a width narrower than the diameter of the length portion of the suture needle held within the needle-holding portion of the slot. A method of forming the suture needle holder is also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 07/975,493,filed Jan. 19, 1993, abandoned, which is a divisional of applicationSer. No. 07/801,552, filed Dec. 2, 1991, now U.S. Pat. No. 5,192,483,issued Mar. 9, 1993.

FIELD OF THE INVENTION

This invention relates to the field of suture needle holders useful forpackaging armed sutures.

BACKGROUND OF THE INVENTION

Suture packages containing armed sutures typically incorporate a meansfor securing the needle to the package so that the needle does not movewhile being grasped with suture forceps. The needle holder must alsosecure the needle from movement during shipping of the package, arequirement that prevents the needle point from possibly causing damageto the suture as well as preventing damage to the needle itself.

Needle holders for suture packages have taken many forms. Frequently,the point of the needle is inserted through a piece of plastic foam tohold it secure. The use of flaps cut from the packaging material is alsocommon, the flap compressively holding the needle against the surface ofthe adjacent packaging material. Some flaps incorporate a slit throughwhich a needle is placed, as taught by U.S. Pat. No. 4,884,681. Anotheralternative is described by U.S. Pat. No. 4,961,498, which involves aflexible rail and an adjacent post wherein a needle is held captivebetween the rail and post.

U.S. Pat. No. 4,424,898 teaches the construction of a needle holderincorporating adjacent pedestals having straight slots between theadjacent pedestals, wherein curved needles are fitted into the straightslots. The resulting interference due to the curvature of the needleretains the needle within the straight slot.

U.S. Pat. No. 4,699,271 describes a needle holder using two parallelridges having pairs of shaped slots extending in predetermined curvesacross a U-shaped notch, wherein the curves are chosen to match thecurvature of the needle intended to be fitted into a pair of slots.

SUMMARY OF THE INVENTION

The present invention relates to a suture needle holder for a suturepackage intended to contain an armed suture, comprising a sheet ofplanar plastic having at least one raised pedestal formed therein, theat least one raised pedestal having at least one slot therein orientedorthogonal to the sheet of planar plastic, the at least one slot havingan open portion and a needle-holding portion releasably holding aportion of the length of a suture needle therein with the length of thesuture needle lying in a plane parallel to the sheet of planar plastic,wherein the open portion of the slot is of a width narrower than thediameter of the length portion of the suture needle held within theneedle-holding portion of the slot.

The needle holder is made by forming a sheet of planar plastic with adie having a flat surface, the die having at least one cavity cut intothe flat surface for forming at least one pedestal into the sheet ofplanar plastic, the die further having at least one trough cut into theflat surface for holding a suture needle during forming of the sheet ofplanar plastic, the at least one trough intersecting the at least onecavity, the at least one trough having a depth less than the depth ofthe at least one cavity, wherein thermoforming techniques are used toapply heat and a pressure differential to the sheet of planar plastic tocause the sheet of planar plastic to form a pedestal into the cavity andto form a slot into the pedestal around the length portion of the sutureneedle lying in the intersection of the trough and the cavity. Thepressure differential is preferably accomplished by vacuum formingwherein a vacuum is applied within the cavity or cavities of the die toform at least one slotted needle-holding pedestal into the planarplastic. The portion of the planar plastic intended to be formed intothe pedestal should be heated to aid in the forming process. Anadditional portion of the planar plastic sheet material may be formed topackage and retain the suture, such as by forming serpentine passagewaysinto the planar plastic sheet. It is anticipated that the inventiveneedle-holder will be made as a part of a complete suture packagecapable of withstanding ordinary sterilization methods. Such a packagewould typically be enclosed in a protective bacteria impermeableenvelope. The envelope may be partially or entirely made from a gas orsteam permeable material for gas or steam sterilization. Because thesheet of planar plastic can function as an effective bacterial barrierin its own right, a practical package can be made by simply sealing asheet of a protective bacteria impermeable material to the perimeter ofthe sheet of planar plastic. At least a portion of this sheet may alsobe made from a steam or gas permeable material if steam or gassterilization is desired. Tyvek®, available from du Pont de Nemours,Inc. (Wilmington, Del.), is one such steam and gas permeable, bacteriaimpermeable sheet material.

The inventive needle holder capable of holding a range of needle sizesmay be formed from a single die; further, the needle holder forming stepis simultaneous with the packaging of the needle because the pedestaland slot are formed around the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 describes a perspective view of a suture package made of a sheetof planar plastic and incorporating a suture needle holder of thepresent invention.

FIGS. 1A and 1B describe end and transverse cross sectional viewsrespectively of the suture needle holder of the present invention.

FIG. 1C describes a transverse cross sectional view of an alternativeembodiment designed to hold two needles.

FIG. 2 describes a perspective view of a die useful for forming thesuture needle holder of the present invention.

FIGS. 2A and 2B describe end and transverse cross sectional viewsrespectively of the die of FIG. 2 containing a suture needle as intendedfor use during forming of the suture needle holder.

FIG. 2C describes a perspective view of an alternative die.

FIGS. 3A and 3B describe side and end and transverse cross sectionalviews respectively of an alternative embodiment of the suture needleholder incorporating supporting projections extending outwardly from thepedestal sides.

FIGS. 4 and 4A describe perspective and end sectional views of analternative embodiment of the present invention incorporating atwo-pedestal suture needle holder.

FIGS. 5A and 5B describe end and side transverse cross sectional viewsrespectively of an alternative embodiment of the suture needle holderdescribed in FIGS. 4 and 4A.

FIG. 6 describes a suture package incorporating the inventive needleholder, sealed within a protective bacteria impermeable envelope.

FIG. 7 describes a sterilizable suture package formed by sealing a sheetof protective bacteria impermeable material to the perimeter of thesheet of planar plastic from which the needle holder was formed.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 describes a perspective view of a suture package made of a sheetof planar plastic and incorporating a suture needle holder of thepresent invention. It is apparent that the needle holder may be anintegral part of a complete suture package.

The needle holder 10 is formed from a portion of a sheet 12 of planarplastic from which the entire package may be formed. The needle holder10 comprises a raised pedestal 14 having at least one slot 16 formedtherein to releasably retain a suture needle 18. The pedestal 14 andslot 16 are formed around the needle 18 during the packaging process sothat a single forming die may be used to form needle holders for a widevariety of needle sizes.

An additional portion of the sheet of planar plastic 12 may be used topackage and retain a length of suture 19 attached to the needle 18, suchas by the use of a formed serpentine passageway 17.

FIGS. 1A and 1B describe end and transverse cross sectional viewsrespectively of the inventive needle holder. FIG. 1A shows that thepedestal 14 and slot 16 can be formed to hold the needle 18 in a waythat provides a clearance 20 between the needle and the surface of thesheet 12 of planar plastic. The provision of clearance 20 allowsimproved ease of grasping of the needle 18 by conventional sutureforceps. FIG. 1B shows that the width 22 of the slot 16 is made to besignificantly narrower than the diameter of the needle portion 24retained within the slot 16. The width 22 of the slot 16 should be about5 to 95 percent of the diameter of the needle portion 24 intended to beretained by the slot 16. A more preferred range is for the slot width tobe about 50 to 95 percent of the diameter of the retained needleportion. This relationship provides for adequately secure retention ofthe needle while allowing the needle to be easily removed with a minimumof force. The relationship between slot width and needle diameter is theresult of the amount of heat and the quantity of pressure differentialapplied to the sheet of planar plastic during the forming process. Thedepth of the cavity extending beyond the depth of the trough can alsoaffect this relationship.

It is believed that a useful needle holder of the present invention maybe made using a thin sheet 12 of planar plastic wherein the two opposingsides of the slot 16 retaining the needle are actually in contact witheach other but not thermally fused together, that is, the slot width iseffectively 0 percent of the diameter of the retained needle portion 24.

The needle is typically removed from the needle holder by grasping anexposed portion of the needle with suture forceps and lifting itupwardly out of the slot in a direction generally orthogonal to theplanar surface of the needle holder and suture package.

FIG. 1C describes a transverse cross sectional view of an alternativepedestal 14 providing two slots 16 for retaining two needles 18. It isapparent that as many needle retaining slots can be provided within asingle pedestal 14 as desired as long as a practical amount ofseparation is provided between adjacent needles in order to allow fortheir individual removal.

FIG. 2 describes a perspective view of a die for forming the needleholder of the present invention. The die 30 has a flat surface 32 onwhich the sheet of planar plastic intended to be formed is laid. Theflat surface 32 is interrupted by a cavity 34 and a trough 36 whichintersects the cavity 34. Cavity 34 is used to form the pedestal 14 ofthe needle holder 10 while the trough 36 holds the suture needle 18during the forming process. As shown, the depth of cavity 34 must begreater than the depth of the trough 36. Cavity 34 preferably provides ameans for producing a pressure differential across the two opposingsurfaces of the sheet of planar plastic during the forming process suchas vacuum ports 38. Alternatively, a positive pressure may be applied tothe opposite side of the sheet of planar plastic during forming.Likewise, a positive pressure may be used simultaneously with a vacuum.Trough 36 should be of depth greater than the diameter of the needleportion 24 intended to be held by the slot 16 within the pedestal. Thedifference between the diameter of the needle portion 24 and the depthof the trough 36 will be the clearance 20 between the needle 18 and thesurface of the sheet 12 of planar plastic in the finished needle holder10. The floor 39 of the needle trough 36 may optionally be made of amagnetic material to aid in holding the needle 18 in place within thetrough 36 during the forming process.

As shown by the end sectional view of FIG. 2A, the needle holder 10 isformed by placing a needle 18 into the trough 36 prior to placing asheet 12 of planar plastic onto the flat surface 32 of the die 30. Apressure differential is created across the two opposing sides of thesheet 12 of planar plastic above the cavity 34 of the die 30, with thehigher relative pressure applied to the portion 37 of the side of thesheet 12 of planar plastic opposing the cavity 34. This is preferablyaccomplished by pulling a vacuum within the cavity through optionalvacuum ports 38 in the floor of the cavity. The portion 37 of the sideof the sheet 12 of planar plastic intended to be deformed into thecavity 34 to form the pedestal 14 should be heated to aid in the formingprocess. The heat may be applied, for example, by hot air or bymomentarily contacting the portion 37 of the side of the sheet 12 ofplanar plastic opposite the die cavity 34 with a heated metal shoe. Theamount of heat and the time of its application are the most criticalparameters in the needle holder forming process. As shown by thetransverse cross sectional view of FIG. 2B, the presence of a sutureneedle 18 within the trough 36 and spanning the cavity 34 results in theformation of the pedestal 14 around the needle 18, simultaneouslycapturing the needle 18 and forming the slot 16 within the pedestal 14.The amount of pressure differential, heat and time of application, inconjunction with the thickness of the sheet 12 of planar plastic and thetype of plastic used, will control the width 22 of the slot 16.

FIG. 2C describes an alternative die 31. In the embodiment shown, thedie 31 incorporates two pairs of grooves 42 to allow it to produce aneedle holder for retaining two needles. For clarity, only one needle 18is shown held by one pair of grooves 42. It is apparent that a die maybe configured with as many troughs 36 or pairs of grooves 42 as requiredto hold the desired number of needles 18. In the embodiment of FIG. 2C arim 44 surrounds cavity 34. The depth of grooves 42 corresponds to thedepth of trough 36 described previously. The flat surface 46 of the diesurrounding rim 44 is recessed below the rim 44 only for convenience ofplacing the needle. The recession of the flat surface 46 is not intendedto cause significant deformation of the planar plastic into this areaand consequently there is no differential pressure or heat applied tothe sheet of planar plastic immediately above flat surface 46 during theforming process. Magnets 48 are provided to hold the needles securelyduring the forming process; the surface of the magnets 48 should lie inthe same plane as the floor 49 of the grooves 42.

The advantage of the die described by FIG. 2C is that it is able toaccommodate a wider variety of needle shapes, from straight needles tohighly curved needles. A die of the type shown by FIGS. 2, 2A and 2Bincorporating a trough will only accommodate needles fitting the shapeof the trough.

FIGS. 3A and 3B show end and transverse cross sectional viewsrespectively of a variation of the needle holder wherein a supportingprojection 52 extends outwardly away from the sides of the pedestal 14and lies between a portion of the needle adjacent to the pedestal andthe plane of the sheet 12 of planar plastic prior to forming. Supportingprojection 52 results from deformation of the sheet 12 of planar plasticinto the corresponding die space during forming. The supportingprojection 52 is useful to further support the needle 18 and increasethe stability of the needle within the needle holder.

FIGS. 4 and 4A show perspective and end sectional views of analternative embodiment of the needle holder wherein each needle 18 isheld by two pedestals 14 with each pedestal having a slot for holdingdifferent length portions of the same needle 18. A needle holderincorporating two pedestals may be desirable when it is intended to makethe center portion of the needle length available for grasping withsuture forceps.

FIGS. 5A and 5B show end and transverse cross sectional views of avariation of the embodiment of FIGS. 4 and 4A wherein a supportingprojection 54 extends between the pedestals into the space between theneedle and the plane of the sheet of planar plastic prior to forming.

FIG. 6 shows the needle holder as a part of an armed suture packageenclosed by a protective envelope 61 intended to allow the suture andpackage to be sterilized and maintained sterile until the envelope isopened. The envelope 61 can be made at least partially from a steam andgas permeable, bacteria impermeable material if steam or gassterilization is desired. FIG. 7 shows an alternative sterilizablesuture package wherein a cover sheet 71 of protective bacteriaimpermeable material is sealed around the perimeter of the sheet 12 ofplanar plastic from which the needle holder was formed. The cover sheet71 may be made at least partially from a steam and gas permeablematerial if steam or gas sterilization is desired. The sealedsterilizable packages represented by FIGS. 6 and 7 may additionally besealed in outer protective envelopes (not shown) for mechanical andsterility protection until ready for use.

The suture needle holder and suture package may be formed from varioustypes of thermoplastic sheet materials including polypropylene,polyethylene terephthalate, polycarbonate, polyethylene, polyvinylchloride and polystyrene. It is also anticipated that formable metalfoils may also be useful for the needle holder of the present inventionusing ordinary metal foil forming technology.

I claim:
 1. A suture needle holder for a suture package comprising asheet of planar plastic having at least one raised pedestal therein,said sheet of planar plastic having a substantially uniform thickness sothat said at least one raised pedestal comprises the substantiallyuniform thickness, said at least one raised pedestal having at least oneslot therein, said at least one slot comprising two opposing surfacesoriented orthogonal to the sheet of planar plastic, said at least oneslot having an open portion and a needle-holding portion releasablyholding a portion of the length of a suture needle there in with thelength of the suture needle lying in a plane parallel to the sheet ofplanar plastic, wherein the portion of the length of the suture needlehas a diameter and a surface, wherein the open portion of the slot is ofa width narrower than the diameter of the portion of the length of thesuture needle held within the needle-holding portion of the slot,wherein the two opposing surfaces of the at least one slot intersect thesurface of the portion of the length of the suture needle, and whereinthe two opposing surfaces are substantially symmetrical with each otherin transverse cross section.
 2. A suture needle holder according toclaim 1 wherein the open portion of the slot is of width equal to about5 to 95 percent of the diameter of the length portion of the sutureneedle held within the needle holding portion of the slot.
 3. A sutureneedle holder according to claim 2 wherein the open portion of the slotis of width equal to about 50 to 95 percent of the diameter of thelength portion of the suture needle held within the needle holdingportion of the slot.
 4. A suture needle holder according to claim 1wherein said raised pedestal has two opposing sides orientedsubstantially orthogonal to the sheet of planar plastic and to theportion of the length of the suture needle, and wherein supportingprojections extend outwardly away from the two opposing sides of thepedestal between the sheet of planar plastic and the portions of thesuture needle adjacent to the pedestal.
 5. A suture needle holderaccording to claim 1 having two raised pedestals.
 6. A suture needleholder according to claim 5 wherein a supporting projection extendsbetween the two raised pedestals and between the sheet of planar plasticand a portion of the suture needle between the two pedestals.
 7. Asuture needle holder according to claim 1 wherein the needle holder is apart of a suture package containing at least one suture which isattached to the suture needle.
 8. A suture needle holder according toclaim 1 wherein the sheet of planar plastic is selected from the groupcomprising polypropylene, polyethylene terephthalate, polycarbonate,polyethylene, polyvinyl chloride and polystyrene.
 9. A suture needleholder according to claim 1 wherein the perimeter of the sheet of planarplastic has been sealed to a sheet of protective bacteria impermeablematerial.
 10. A suture needle holder according to claim 9 wherein atleast a portion of the sheet of protective bacteria impermeable materialis made from a steam and gas permeable material.
 11. A suture needleholder according to claim 1 wherein the needle holder has been sealedwithin a protective bacteria impermeable envelope to form a sealedpackage.
 12. A suture needle holder according to claim 11 wherein thesealed package has been sterilized.